Sanofi Pasteur Global Dengue Vaccine Clinical Program Expanded in Latin America

Thursday, December 10, 2009 Dengue News
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MEXICO CITY, December 9 Sanofi Pasteur, thevaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY),announced today the expansion of its dengue vaccine clinical program in LatinAmerica with a new multicenter study in children and adolescent in Mexico,Colombia, Honduras and Puerto Rico. This new multicenter study complements anearlier study in Mexico and an ongoing study in Peru.

These studies are aimed at advancing the development of a novel vaccinefor the prevention of dengue infections in Latin America. Currently, there isno specific treatment available against dengue fever, which is the mostwidespread tropical disease after malaria.

"Latin America was considered almost free of dengue in the 1960s. Sincethen, urbanization and travel have contributed to the fast re-emergence ofthe disease. Today, dengue disease is a severe public health issue throughoutLatin America," said Dr. Roberto Tapia-Conyer, Director General at CarsoHealth Institute. "So far, controlling the mosquitoes that transmit denguedidn't stop this trend. A safe and effective vaccine would be most welcome toprevent dengue epidemics in the region."

Dengue in Latin America: a growing burden

Nineteen Latin American countries were certified as dengue free between1952 and 1965. The first reappearance of dengue fever was recorded in 1968,and by 2007 the disease had once more taken hold in all those countries [1].In 2008 and 2009, severe dengue epidemics have been reported in Mexico,Paraguay, Brazil, Bolivia and Argentina. Many factors have contributed to there-emergence and dramatic increase in dengue fever including urbanization andincreased travel which facilitates dissemination of dengue viruses and thecirculation of all four dengue serotypes in the region.

"Fighting dengue is of the utmost public health importance: We mustremain on epidemiological alert as dengue continues to circulate in LatinAmerica", said Dr. Jorge Mendez, Investigator at the children's hospitalFederico Gomez in Mexico and co-investigator for the evaluation of a denguevaccine in Mexico. "Clinical studies in Mexico are critical steps to advancethe development of a vaccine for the prevention of dengue. We are happy thatMexico contributes to scientific research that would benefit the entireregion."

"Most of the severe dengue cases are among children under the age of 15years old. It is an important cause of hospitalization which contributeshighly to the burden of disease and increases costs for our health system,"said Dr. Diana Patricia Rojas Alvarez, Expert for vector born diseases,dengue and yellow fever, at the National Institute of Health in Colombia. "Asafe and effective vaccine for children is much needed and we are pleased tosupport pediatric clinical studies in Colombia."

Sanofi Pasteur global clinical study program for a dengue vaccine

Sanofi Pasteur started the development of a dengue vaccine in the '90s.Clinical studies with its most advanced tetravalent candidate vaccine startedin the 2000s. Sanofi Pasteur's dengue vaccine candidate has been evaluated inclinical trials (Phase I, II) in adults and children from non-endemic (U.S.)and endemic countries (Mexico, Philippines). Overall, a balanced immuneresponse against all four serotypes was observed after three doses of thevaccine. The vaccine appears to be well tolerated with a similar safetyprofile after each dose [2].

Sanofi Pasteur's dengue vaccine research program includes ongoingclinical studies with adults and children in Mexico, Colombia, Honduras,Puerto Rico, Peru, the Philippines, Vietnam, Singapore, and Thailand. Thesestudies follow the highest standards from the International Conference onHarmonization of Technical Requirements for Registration of Pharmaceuticalsfor Human Use (ICH). Sanofi Pasteur's tetravalent dengue vaccine is theleading dengue candidate vaccine in development [3,4].

About dengue fever

Dengue fever is a mosquito-borne disease caused by four types of dengueviruses (type 1 to 4). Overall, the disease is a potential threat for almosthalf of the world's population. Of the estimated 230 million people infectedannually, two million, mostly children, develop dengue hemorrhagic fever(DHF), a severe form of the disease [5]. DHF is a leading cause ofhospitalization, placing tremendous pressure on strained medical resources.

Dengue fever occurs mostly in tropical and subtropical countries in Asiaand Latin America and is spreading to new parts of the globe each year. Inaddition, dengue affects countries such as Australia (Queensland) and theUnited States (Puerto Rico, Texas-Mexico border, Hawaii and the US-affiliatedPacific Islands). A substantial number of people traveling to endemic regionsare also infected each year.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers,develops and distributes therapeutic solutions to improve the lives ofeveryone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York(NYSE: SNY). For more information, visit:

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, providedmore than 1.6 billion doses of vaccine in 2008, making it possible toimmunize more than 500 million people across the globe. A world leader in thevaccine industry, Sanofi Pasteur offers the broadest range of vaccinesprotecting against 20 infectious diseases. The company's heritage, to createvaccines that protect life, dates back more than a century. Sanofi Pasteur isthe largest company entirely dedicated to vaccines. Every day, the companyinvests more than EUR 1 million in research and development. For moreinformation, please visit: or

Forward Looking Statements

This press release contains forward-looking statements as defined in thePrivate Securities Litigation Reform Act of 1995, as amended. Forward-lookingstatements are statements that are not historical facts. These statementsinclude financial projections and estimates and their underlying assumptions,statements regarding plans, objectives, intentions and expectations withrespect to future events, operations, products and services, and statementsregarding future performance. Forward-looking statements are generallyidentified by the words "expects," "anticipates," "believes," "intends,""estimates," "plans" and similar expressions. Although sanofi-aventis'management believes that the expectations reflected in such forward-lookingstatements are reasonable, investors are cautioned that forward-lookinginformation and statements are subject to various risks and uncertainties,many of which are difficult to predict and generally beyond the control ofsanofi-aventis, that could cause actual results and developments to differmaterially from those expressed in, or implied or projected by, theforward-looking information and statements. These risks and uncertaintiesinclude those discussed or identified in the public filings with the SEC andthe AMF made by sanofi-aventis, including those listed under "Risk Factors"and "Cautionary Statement Regarding Forward-Looking Statements" insanofi-aventis' annual report on Form 20-F for the year ended December 31,2008. Other than as required by applicable law, sanofi-aventis does notundertake any obligation to update or revise any forward-looking informationor statements.


1. Roberto Tapia-Conyer, Jorge F. Mendez-Galvan, Hector Gallardo-Rincon,The growing burden of dengue in Latin America, Journal of Clinical Virology,vol 46, September 2009

2. Bouckenooghe et al presented at 57th ASTMH annual meeting, NewOrleans, December 2008

3. Dengue vaccine efficacy trials in progress,, vol 9, November 2009

4. Jean Lang, Recent progress on Sanofi Pasteur's dengue vaccinecandidate. Journal of Clinical Virology 46, S2 (2009) 20-24

5. Beatty M Letson GW Margolis HS, Estimating the global burden ofdengue., Am J Trop Med Hygiene 81, 5 :231 2009

SOURCE Sanofi Pasteur

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